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Globus Medical received FDA 510(k) clearance for Excelsius3D, an intelligent intraoperative 3-in-1 imaging system. The company is ramping up production and preparing for commercial release in 4Q21.
Excelsius3D is a 3-in-1 imaging platform that consolidates 360° cone-beam CT, fluoroscopy, and high-resolution digital radiography into one unified solution. A mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients, the technology eliminates the need for multiple imaging systems during one procedure, functioning as an elite, standalone unit.
Excelsius3D is an extension of Globus Medical’s Excelsius ecosystem, which includes robotic and navigation technology.
“Excelsius3D underwent rigorous performance testing of various capabilities to support this 510(k) clearance, as it is our first imaging system 510(k) to be filed with the FDA’s Office of In Vitro Diagnostics and Radiological Health,” said Kelly Baker, Ph.D., Senior Vice President, Regulatory and Clinical Affairs. “We are excited to expand into a new product space with the FDA and help bring this truly innovative system to market.”
